Phase 3 Study Results Highlighting Deucrictibant’s Rapid and Sustained Efficacy in Treating HAE Attacks Published in The Lancet
Key Highlights
- ➤Deucrictibant IR cut symptom-relief onset to 1.28 hours in Phase 3 RAPIDe-3
- ➤Deucrictibant IR achieved complete symptom resolution in 11.95 hours
- ➤RAPIDe-3 met primary and all 11 secondary endpoints with high statistical significance
- ➤FDA NDA review targets April 23, 2027 PDUFA action date
- ➤EMA is reviewing Pharvaris’ MAA for on-demand HAE attack treatment
Expert Statements
Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association Angioedema Center at the University of California San Diego, principal RAPIDe-3 study investigator, and lead Author of the publication
“Bradykinin B2 receptor antagonism is a validated and reliable mechanism currently being widely used for the on-demand treatment of HAE attacks”
Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association Angioedema Center at the University of California San Diego, principal RAPIDe-3 study investigator, and lead Author of the publication
“The results of the RAPIDe-3 study demonstrate that deucrictibant IR, an orally-administered bradykinin B2 receptor antagonist, rapidly ended attack progression and accelerated the time to complete symptom resolution.”
Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association Angioedema Center at the University of California San Diego, principal RAPIDe-3 study investigator, and lead Author of the publication
“Publication in The Lancet, one of the world’s highest-impact academic journals, maximizes the visibility of these data to a global network of clinicians, researchers, and patients.”
Marc A. Riedl, M.D., M.S., Professor of Medicine, Clinical Director of the U.S. Hereditary Angioedema Association Angioedema Center at the University of California San Diego, principal RAPIDe-3 study investigator, and lead Author of the publication
“If approved, deucrictibant IR will be the first approved oral bradykinin B2 receptor antagonist, with the potential to address unmet needs of people living with HAE by providing reliable symptom relief and resolution with a single convenient oral capsule.”
Peng Lu, M.D., Ph.D., President of Pharvaris
“the consistent results from RAPIDe-3 across subgroups underscores the clinical relevance of antagonizing the bradykinin B2 receptor, a downstream target that stops the effects of excess bradykinin regardless of the pathways through which it is generated.”
Peng Lu, M.D., Ph.D., President of Pharvaris
“These findings represent the first pivotal step in Pharvaris’ broader clinical development strategy of investigating deucrictibant across both on-demand and prophylactic settings with the goal of delivering new treatment options that may address unmet medical needs of those living with bradykinin-mediated angioedema.”
* Results from RAPIDe-3 demonstrate that treatment with deucrictibant IR resulted in faster time to onset of symptom relief (1.28 hours) and to complete symptom resolution (11.95 hours) * Deucrictibant IR showed a well-tolerated safety profile * NDA and MAA of deucrictibant IR for the on-demand treatment of HAE attacks under review by regulatory authorities ZUG, Switzerland, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated angioedema, such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced that results of RAPIDe-3, a phase 3, global, randomized, double-blind, placebo-controlled crossover study evaluating oral deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of HAE attacks in adolescents and adults have been published in The Lancet (Journal Impact Factor: 109.0).
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